FDA Approves New Abuse-Deterrent Opioid

The FDA has approved Arymo ER, a long-acting opioid painkiller.

The approval follows a vote from an independent panel of advisors to the FDA in August recommending that the drug be labeled as an abuse-deterrent product via oral, nasal, and intravenous routes. However, the FDA has only approved the claim that the drug deters abuse via intravenous routes. 
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Arymo ER (morphine sulfate extended-release tablets) is intended to treat severe pain that requires daily, long-term opioid treatment for which alternative treatments are inadequate. The pill is designed to be difficult to crush and manipulate by those attempting to abuse it.

The drug was approved in 3 dosages: 15 mg, 30 mg, and 60 mg.

—Michael Potts

Reference:

Egalet. Egalet receives FDA approval for ARYMO™ ER (morphine sulfate) c-ii, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain [press release]. January 9, 2017. http://egalet.investorroom.com/2017-01-09-Egalet-Receives-FDA-Approval-for-ARYMO-ER-morphine-sulfate-C-II-an-Extended-Release-Morphine-Product-Formulated-with-Abuse-Deterrent-Properties-for-Treatment-of-Chronic-Pain.